ICS 11.040.01                         MHD 14

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 14971 : 2019 'Medical devices - Application of risk management to medical devices' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2018 which was identical with ISO 14971 : 2007 'Medical devices - Application of risk management to medical devices'. The first revision of this standard has been undertaken to align it with the latest version of ISO 14971 : 2019.

The text of the ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words 'International Standard' appears referring to this standard, they should be read as 'Indian Standard'.

b) Comma (,) has been used as a decimal marker, while in Indian Standard, the current practice is to use a point (.) as the decimal marker.